A Multi-Reader Multi-Case Pivotal Trial

NCT02692209 | Completed Results

• 1 other identifier: FMSU2013-004G
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

Conditions

Breast Cancer

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.

  The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result.

  1 month

Study Arms (2)

FFDM Plus DBT

FFDM Plus DBT images are being evaluated as compared to FFDM alone

Device: FFDM Plus DBT

Full Field Digital Mammography

Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT

Device: FFDM Alone

Interventions

FFDM Plus DBT DEVICE

FFDM + DBT Images FujiFilm Aspire Cristalle System

FFDM Plus DBT

FFDM Alone DEVICE

FFDM Alone Images

Full Field Digital Mammography

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This research is a retrospective study with an enriched sample of breast screening or diagnostic cases that were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A.

You may qualify if:

• Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.

You may not qualify if:

• Subjects who are in violation of protocol FMSU2013-004A.
• Subjects with unknown clinical status.
• Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (5)

Scottsdale Medical Imaging, Ltd

Scottsdale, Arizona, 85258, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Elizabeth Wende Breast Care, LLC (EWBC)

Rochester, New York, 14620, United States

Location

University of North Carolina - at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Randy Vader
• Organization: Fujifilm Medical Systems USA, Inc.

randy.vader@fujifilm.com

360-356-6821

Study Officials

• Robert M Uzenoff

  Fujifilm Medical Systems USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: February 25, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 7, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)